PHARMACEUTICAL ANALYSIS AT MCA SERVICES The   physical   characteristics   of   pharmaceutical   forms   are   often   critical   to   their   ultimate   effectiveness.   Knowledge,   understanding   and   control   of   physical properties    is    fundamentally    important    to    every    phase    of    pharmaceutical    formulation,    evaluation,    production    and    QC.    Quantification    of    physical properties are often classified as being critical within a QbD framework. The   porous   characteristics   of   pharmaceuticals   in   many   forms,   such   as   APIs,   excipients,   powder   blends,   granules   and   solid   dosages   are   influential   to pharmaceutical   performance   and   efficiency   and   have   direct   effects   on   dissolution   rate,   solubility,   tablet   strength   and   hardness,   long   term   stability   and shelf-life.  Key Benefits: • Assessment of API and excipient materials • Analysis of many pharmaceutical forms • Investigation of batch failures • Investigation of batch-to-batch variability • Determination of long-term stability & shelf-life • Identification of counterfeit pharmaceuticals • Data interpretation included as standard • All analyses undertaken to ISO 17025:2017 • Adaptable to different test methods Measurement    of    specific    surface    area    (SSA),    pore    volume,    average    pore    size    and    pore    size    distribution    provides    essential    information    for    the characterisation   of   the   porous   nature   of   pharmaceuticals.   Porosity   within   pharmaceutical   materials   can   be   present   in   various   locations:   within   tablet cores   and   coatings,   granules,   pre-cursor   power   blend   particles   as   well   as   the   inter-particle   voids   within   powder   blends.   All   have   profound   effects   on pharmaceutical   efficiency   and   the   characterisation   of   powder   blends   allows   for   predictions   of   the   solid   dosage   form   to   be   made   and   for   variability   to   be traced. Gas    Adsorption    is    typically    used    for    SSA    measurement,    using    either    nitrogen    or    krypton    adsorption.    Mercury    Porosimetry    is    used    for    the    full characterisation of pore volume and pore size and is more informative than SSA by gas adsorption data alone.    Key Techniques: • BET surface area (SSA) by nitrogen • BET surface area (SSA) by krypton for low area samples • Mercury Porosimetry for pore volume measurement • Mercury Porosimetry for pore size distribution • Mercury Porosimetry for volume (%) porosity measurement • Micropore analysis for pore volume, area and size measurement • Bulk (envelope) density measurement • Analysis of powder blends • Analysis of solid dosage forms At   MCA   Services   we   offer   a   complete   suite   of   techniques   for   the   characterisation   of   sample   porosity   with   the   experience   and   expertise   to   actively   assist with   the   interpretation   of   results   and   their   relation   to   development   and   performance   criteria.   Our   ongoing   in-house   research   continues   to   highlight   the significance of and application of these analytical techniques to the pharmaceutical sector.